AccessGUDID - DEVICE: Silk'n (17290015418864)

GUDID

Device Identifier (DI) Information

Brand Name: Silk'n
Version or Model: Flash & Go Express
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7290015418867
Company Name: HOME SKINOVATIONS LTD

Primary DI Number: 17290015418864
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514891048 *Terms of Use

Device Description: An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47704	Cosmetic red-light phototherapy system, home-use	An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
OHT	Light Based Over-The-Counter Hair Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141242	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac12c8dd-92fc-468b-922f-a78c60254ee0
Public Version Date: June 12, 2023
Public Version Number: 8
DI Record Publish Date: August 15, 2016